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The Effect of the Use of Computer Game- "My Diabetic Friend" in Children With Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Interactive computer game
Convertible PC
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Type 1 diabetes, "My Diabetic friend", interactive computer game

Eligibility Criteria

7 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Type 1 diabetes diagnosed at least one year prior to study entry.
  2. Age:7-11 years old.
  3. Treatment either with CSII or MDI.
  4. HbA1c>8.0%
  5. Signing an informed consent form.

Exclusion Criteria:

  1. Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to affect subject compliance or subject's ability to complete the study.
  2. Inability to understand/ complete the questionnaires.

Sites / Locations

  • Schneider Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

interactive computer game

Convertible PC

Arm Description

Participants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC.

Participants will be using the convertible classmate PC without the interactive computer game

Outcomes

Primary Outcome Measures

Quality of life
Quality of life questionnaires will be completed

Secondary Outcome Measures

Metabolic control
HbA1c will be measured
Diabetes knowledge
Diabetes knowledge questionnaires will be completed
Patient's gaming duration
The frequency and the duration of use of the interactive computer game by each participant will be monitored by the study team
Compliance to diabetes treatment
Patient's parents will undergo clinical interview about patient's diabetes adherence
Average glucose levels
Average number of blood glucose measurements
Measurements within normal range
Hypoglycemia events
Hyperglycemia events

Full Information

First Posted
May 16, 2012
Last Updated
May 4, 2014
Sponsor
Rabin Medical Center
Collaborators
Intel Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01600664
Brief Title
The Effect of the Use of Computer Game- "My Diabetic Friend" in Children With Type 1 Diabetes
Official Title
Randomized Controlled Trial to Evaluate the Effect of 3 Months Use With Interactive Computer Game- "My Diabetic Friend"-Comparing to Conventional Diabetes Education on Metabolic Control, Quality of Life and Diabetes Knowledge in Children With Type 1 Diabetes.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
Collaborators
Intel Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized controlled study to evaluate the effect of 3 months use with interactive computer game- "My Diabetic Friend"- comparing to conventional diabetes education on metabolic control, quality of life and diabetes knowledge.Patients will be randomized into two groups- one group will be supplied with interactive computer game, "My Diabetic friend", installed on a computer designed for children's educational needs for a period of three months and the other group will be supplied with the same computer without the interactive computer game for three months. Metabolic control, quality of life and diabetes knowledge will be evaluated before and after the use of the computer. The trial is consisting of two main periods: 3 months of the main study period and an optional extension period consisting of the following 3 months : The study will include two main periods; Period 1 which will last 3 months, in a randomized controlled manner, this period will serve as the main study period to assess the primary and secondary endpoints of the study. Period 2: this extension period will not be an integral part of the study, and only patients who are willing will take part at this period, will continue to participate at the optional extension period. During the extension period, patients in the intervention group will be offered to continue the use of the Computer game -"My diabetic friend) for the following 3 months, and patients who participated at the control group during period 1, will be offered to start to use the Computer Game - "My Diabetic Friend" for the following 3 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, "My Diabetic friend", interactive computer game

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
interactive computer game
Arm Type
Experimental
Arm Description
Participants will be using the interactive computer game- "My Diabetic Friend", installed on Intel-powered convertible classmate PC.
Arm Title
Convertible PC
Arm Type
Active Comparator
Arm Description
Participants will be using the convertible classmate PC without the interactive computer game
Intervention Type
Behavioral
Intervention Name(s)
Interactive computer game
Intervention Description
Participants will use the interactive computer game installed on a convertible PC
Intervention Type
Behavioral
Intervention Name(s)
Convertible PC
Intervention Description
Participants will be using the convertible PC without the interactive computer game
Primary Outcome Measure Information:
Title
Quality of life
Description
Quality of life questionnaires will be completed
Time Frame
After 12 weeks (end of study)
Secondary Outcome Measure Information:
Title
Metabolic control
Description
HbA1c will be measured
Time Frame
After 12 weeks (end of study)
Title
Diabetes knowledge
Description
Diabetes knowledge questionnaires will be completed
Time Frame
After 12 weeks
Title
Patient's gaming duration
Description
The frequency and the duration of use of the interactive computer game by each participant will be monitored by the study team
Time Frame
After 12 weeks
Title
Compliance to diabetes treatment
Description
Patient's parents will undergo clinical interview about patient's diabetes adherence
Time Frame
After 12 weeks
Title
Average glucose levels
Time Frame
After 12 weeks (end of study)
Title
Average number of blood glucose measurements
Time Frame
After 12 weeks (end of study)
Title
Measurements within normal range
Time Frame
After 12 weeks (end of study)
Title
Hypoglycemia events
Time Frame
After 12 weeks (end of study)
Title
Hyperglycemia events
Time Frame
After 12 weeks (end of study)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 1 diabetes diagnosed at least one year prior to study entry. Age:7-11 years old. Treatment either with CSII or MDI. HbA1c>8.0% Signing an informed consent form. Exclusion Criteria: Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to affect subject compliance or subject's ability to complete the study. Inability to understand/ complete the questionnaires.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moshe Phillip, Prof
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Medical Center
City
Petach- Tikva
Country
Israel

12. IPD Sharing Statement

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The Effect of the Use of Computer Game- "My Diabetic Friend" in Children With Type 1 Diabetes

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